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RE-FIT: Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02921126
Collaborator
Pfizer (Industry)
9,914
Enrollment
1
Location
15.1
Actual Duration (Months)
657.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To quantify rates of bleeding events and investigate the characteristics of prescribed patients, rates of bleeding events, persistence and healthcare resource utilization of Oral Anticoagulants (OACs) prescribed in routine clinical practice.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    9914 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy
    Actual Study Start Date :
    Apr 30, 2017
    Actual Primary Completion Date :
    Aug 2, 2018
    Actual Study Completion Date :
    Aug 2, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    High Dose Group

    Apixaban - 10 mg/day Rivaroxaban - 20 mg/day Dabigatran - 300 mg/day
    Low Dose Group

    Apixaban - 5 mg/day Rivaroxaban - 15 mg/day Dabigatran - 220 mg/day
    Other Dose Group

    Invalid Doses / Off-Label

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of clinically relevant bleeding events among Non-valvular atrial fibrillation (NVAF) patients following treatment initiation on an oral OAC in Italy [Approximately 30 months]

    Secondary Outcome Measures

    1. Distribution of patient demographics at the time of OAC initiation [at baseline]

    2. Distribution of clinical characteristics at the time of OAC initiation [at baseline]

    3. Composite of number and percentage of patients who are persistent with their newly prescribed OAC [Approximately 30 months]

    4. Incidence of major bleeding events following treatment initiation among NVAF patients following treatment initiation on an oral OAC in Italy [Approximately 30 months]

    5. Composite of number and percentage of patients with major bleeding events, thromboembolic events, or death while exposed to the newly prescribed OAC [Approximately 30 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • are at least 18 years of age at index date

    • Initiated new OAC therapy ( no previous prescriptions of the same index OAC in the last 12 months prior to the index date ) during the study period

    • Had at least 1 claim with diagnosis of AF anytime in their records

    Exclusion Criteria:

    • Have a record that is indicative of Valvular Atrial Fibrillation during this period

    • Have a history of the OACs prescribed during the study period as assessed during the period of data availability(i.e. history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran or VKA)

    • Have more than one OAC exposure which starts on the same date

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Ravenna Italy 48121

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • Pfizer

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02921126
    Other Study ID Numbers:
    • CV185-494
    First Posted:
    Oct 3, 2016
    Last Update Posted:
    Aug 8, 2018
    Last Verified:
    Aug 1, 2018
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Aug 8, 2018